Study to compare Collagen sheet dressing with Vaseline gauze dressing when used as a dressing material in sites from where skin graft is taken

Not yet recruiting

Conditions: Other intraoperative and postprocedural complications of skin and subcutaneous tissue,

Registration Number: CTRI/2020/02/023207

Lead Sponsor: Armed Forces Medical College

Brief Summary: Splitthickness skin grafting is a common reconstructive technique for the treatmentof patients with deep burns and other traumatic injuries. Various types ofdressing materials are available for the management of donor site afterharvesting a split thickness skin graft such as semi permeable film dressings,semi permeable foam dressings, hydrogels, hydrocolloids, alginate dressings,bioactive wound dressings such as collagen, hyaluronic acid, chitosan andelastin or tissue engineered, medicated and composite dressings. Selection ofan ideal dressing in such vast variety is a challenge. Thus, this study isaimed at most common presentation of the patient which is pain as primaryoutcome and similarly surgical site infection and time of epithelialization as secondaryoutcomes.

Vaseline gauze is a sterile, occlusive dressing consisting of finemesh, absorbent gauze impregnated with approximately three times its weight ofwhite petrolatum.

Collagen sheet is a biological dressing derived from bovinesource, comprising mostly type I and type III collagen which is retained in thetissue and gradually absorbed.

Both dressings are commonly used and there is no ethical issueassociated with their usage.

The primary objective of my study is to compare severity of painwith use of each dressing based on numerical pain rating scale where patientwill rate the severity of his/her pain out of 10 (10 being most severe) on post-operativedays 01, 07, 14 and 21. I have considered pain as primary objective becausethat is what the patient is most considered about. Similarly, my secondaryobjectives are to compare the number of days for epithelialization which is thenumber of days required for healing of the wound and presence or absence ofsurgical site infection. Thus, the study will also compare and analyze withusage of which dressing material the wound will heal faster and in which groupsurgical site infection is common.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

All patients who undergo split thickness skin graft surgery for any indication of the disease and can give consent on their own will be included.

Exclusion Criteria

Immunocompromised patients under cytotoxic drugs or steroids 2.
Any scar at donor site.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare collagen sheet dressing and vaseline gauze dressing in assesing pain based on numerical pain rating scale on post operative days 01,07,14 and 21	days 01,07,14 and 21

Secondary Outcome Measures

Name	Time	Method
To compare days required for epithelialization with use of each dressing	Not applicable
To compare the presence of surgical site infection with use of each dressing	Till the wound is completely healed and patient is under follow up

Trial Locations

Locations (1): Armed Forces Medical College
🇮🇳
Pune, MAHARASHTRA, India
Armed Forces Medical College
🇮🇳Pune, MAHARASHTRA, India
Chiran Bhakta Bista
Principal investigator
8484866623
cbista@gmail.com